OBSERVATIONAL POST-AUTHORISATION SAFETY STUDY OF VISTABEL® FOR THE TREATMENT OF CROW’S FEET LINES (CFL)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, observational, multicenter study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M03AX01) botulinum toxin

  botulinum toxin
• Medical condition to be studied:
  Skin wrinkling

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  580

Study design details

• Main study objective:
  To collect and assess the long-term safety profile of VISTABEL for treatment of CFL
• Data analysis plan:
  Analyses will be performed on de-identified data. Analyses will be descriptive in nature, there are no plans for statistical testing or formal comparisons between groups. Results will be displayed in tabular format (i.e. summary statistics, frequency distribution of item responses, and incidence rates). No imputations for missing data are planned.All statistical analyses will be performed using SAS Version 9.2 or later.